Evaluation of Angioplasty in the Treatment of Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis

This study has been terminated.

(Inability to enroll adequate number of patients)

Sponsor:

Community Care Physicians, P.C.

ClinicalTrials.gov Identifier:

NCT01201707

First Posted: September 15, 2010

Last Update Posted: November 26, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

The study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (CCSVI). In this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these blockages may be associated with symptoms classically attributed to MS. Therefore, angioplasty may help to improve the symptoms associated with CCSVI and multiple sclerosis (MS). In this study, the investigators will evaluate the effectiveness of angioplasty in the treatment of CCSVI by comparing two the outcomes of two groups of patients: one group with CCSVI diagnosed on a venogram and treated with angioplasty and one group with CCSVI diagnosed on a venogram but not treated. The patients enrolled in this study, and the neurologist evaluating patients after the procedure, will not know whether or not they were treated with angioplasty.

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 1 Month ]

This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 3 Months ]

This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 6 Months ]

This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 12 Months ]

This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 18 Months ]

This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Impact of CCSVI treatment on quality of life in patients with MS [ Time Frame: 24 Months ]

This will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54), which is a health-related quality of life measure that combines generic and MS-specific items into a single, self-report questionnaire.

Secondary Outcome Measures:

Clinical significance of CCSVI in MS patients [ Time Frame: 1 month ]

This will be assessed clinically using annualized relapse rates, Expanded Disability Status Scale (EDSS) change and change in the timed 25 foot walk.

Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 1 month ]

This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk

Incidence of CCSVI in patients with MS [ Time Frame: 0 Months ]

This will be assessed on the basis of the findings on diagnostic venography of the internal jugular and azygos veins, which is the initial procedure performed in these patients.

Safety of endovascular treatment of CCSVI [ Time Frame: 1 month ]

This is defined as the number and nature of any procedure-related adverse effects

Target vessel primary and secondary patency [ Time Frame: 1 month ]

Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

This will be assessed clinically using annualized relapse rates, EDSS change and change in the timed 25 foot walk.

Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 6 Months ]

This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk

Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 12 Months ]

This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk

Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 18 Months ]

This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk

Superiority of angioplasty to observation for treatment of CCSVI [ Time Frame: 24 Months ]

This will be assessed clinically using annualized relapse rates, EDSS change, and change in the timed 25-foot walk

Safety of endovascular treatment of CCSVI [ Time Frame: 3 months ]

This is defined as the number and nature of any procedure-related adverse effects

Safety of endovascular treatment of CCSVI [ Time Frame: 6 months ]

This is defined as the number and nature of any procedure-related adverse effects

Safety of endovascular treatment of CCSVI [ Time Frame: 12 months ]

This is defined as the number and nature of any procedure-related adverse effects

Safety of endovascular treatment of CCSVI [ Time Frame: 18 months ]

This is defined as the number and nature of any procedure-related adverse effects

Safety of endovascular treatment of CCSVI [ Time Frame: 24 months ]

This is defined as the number and nature of any procedure-related adverse effects

Target vessel primary and secondary patency [ Time Frame: 3 months ]

Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

Target vessel primary and secondary patency [ Time Frame: 6 months ]

Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

Target vessel primary and secondary patency [ Time Frame: 12 months ]

Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

Target vessel primary and secondary patency [ Time Frame: 18 months ]

Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

Target vessel primary and secondary patency [ Time Frame: 24 months ]

Primary patency is the interval following the initial angioplasty procedure until a reintervention is performed to preserve patency. Secondary patency is defined as the interval following the initial angioplasty procedure until treatment of the vein is abandoned due to an inability to treat the original lesion

At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will be treated with angioplasty.

Procedure: Angioplasty

In this procedure, a small catheter (tube) that is approximately the size of a piece of spaghetti is introduced into the vein that is narrowed based on the findings of the venogram. This catheter has a small balloon on it. That balloon is inflated across the narrowing within the vein with the goal of increasing the diameter of that vein and improving flow within that vein.

Sham Comparator: Observation of CCSVI

At the time of venography, these patients will have had a significant lesion (blockage) in the internal jugular and/or the azygos vein that will not be treated with angioplasty. These patients will be observed after treatment and compared to those patients who received treatment.

Other: Observation

Patients in this arm will be diagnosed with CCSVI based on venography but will receive no intervention. They will be followed in the same manner as patients treated with angioplasty.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years to 60 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients who are willing to comply with the protocol requirements and can be contacted by telephone

Patients with a history of MS as defined above with an EDSS between 3-6.

Patients with a significant stenosis of the internal jugular or azygos vein on the basis of magnetic resonance venography or Doppler ultrasound.

Exclusion Criteria:

Patients with renal insufficiency based on an estimated GFR <45

Patients with a known severe allergy to iodine or gadolinium-based contrast agents which cannot be adequately pre-medicated

Patients with a known allergy to nickel

Patients who pregnant

Patients with a contraindication to anticoagulation or anti-platelet medication

Patients with a contraindication to drugs used for conscious sedation during interventional procedures, including Versed and Fentanyl

Patients with a history of deep venous thrombosis of the lower extremities

Patients with occlusion of the right and left common femoral veins

Patients who have had any changes in their disease modifying drug regimen for MS during the 6 months prior to enrollment in this trial. This would include the addition of any new medications, a change in the dosage of any medications, or the removal of any medications from a patient's drug regimen

Patients with a life expectancy <18 months

Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201707